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5 Steps to Implement ISO Quality Management System
Implementing ISO is not an easy task, I get it. Some companies view this as a mission impossible, a task so big and challenging that is not even worth considering. But what if I had to tell you that you can take these 5 super easy steps to take a big leap towards ISO success…
Visual Management of ISO 9001
Visual Management of ISO 9001 will help to achieve the best out your ISO 9001 Certification. In this blog, I wanted to explain by visually showing you one of the benefits of iso 9001. So what is iso 9001? ISO 9001 is a quality management system that will help you to structure your business in…
The 10 things that can go wrong when implementing ISO 9001 in your organization
In this blog, I will explain the 10 things that can go wrong when implementing ISO 9001. ISO 9001 is a quality management system that has been developed since 1987 with multiple versions of the standard coming out roughly every eight years. I can say that this standard truly helps companies to improve their operational…
External Audits by Certification Bodies
External Audits – What to expect? External Audits by Certification Bodies is the last step before ISO Certification. Many companies tend to get excited about this part as they do not feel that they are ever ready for the audit. However, like any other concept within ISO Certification – this is just another angle through…
ISO 9001:2015 – Internal Audit Criteria with examples
This page is dedicated to helping you learn the art & science of internal auditing. It is by no means a comprehensive list but it gives you the basis of ISO 9001:2015 – Internal Audit Criteria with examples. ISO 9001:2015 – Internal Audit Criteria with examples In this first part, I will give some basic…
Operational Procedures for ISO 9001:2015 Requirements
ISO Certification could easily be described as the most important step you’ll ever do for your business. By Creating Operational Procedures for ISO 9001:2015 certification requirements, you are sure to cater to the most critical elements of your core activities. In turn, by taking a deep dive into these key activities, you are bound to…
ISO Certification vs ISO Accreditation
ISO Certification vs ISO Accreditation are 2 terms that are somewhat used interchangeably, but that however have 2 very different meanings. So, to explain this difference, let’s start from the foundation of what ISO. What is ISO ISO is the International Organisation for Standardisation and its role within the industry is to create standards covering…
ISO 20121 – Sustainable Events
The ISO 20121 – Sustainable Events, just like other standards within the ISO family, is a voluntary standard. This particular standard aims to make a positive impact on the world we live in. ISO 20121 – Sustainable Events, is a practical tool for managing events so that they contribute to the three dimensions of sustainability:…
Recommendations from Certification Bodies
Recommendations from Certification Bodies are always appreciated by ISO consultants who are willing to learn and grow. The following are some of the suggestions that we have received from certification bodies over time. Customer feedback Given that the focus of an ISO 9001 certification is to improve the reliability of our products and services as…
Responsibilities for the Quality Representative
Responsibilities for the Quality Representative is something that thriving business owners think about when embarking on a continual improvement project. Most successful business leaders feel that they would be better off to assign the improvement project to one specific person. The Quality Representative has a very intriguing Job Description as will be highlighted in this…
EUDAMED Registration
In this post, we will go through the information required for EUDAMED Registration and the rationale behind this system. The European Database on Medical Devices (EUDAMED) is an online platform aimed at placing all actors within the Medical Device industry, within EU onto the same platform. Actor, in this context, means any organization that needs…
ISO 22000 Certification – Food Safety Management
Certification to ISO 22000 Certification – Food Safety Management, is a major milestone for aspiring companies within the food industry. In a previous post, we have already discussed the various management systems that exist within the ISO family. In this post, we will go deeper into what ISO 22000 Certification – Food Safety Management really…
Sales and Marketing Procedure as per ISO 9001 requirements
One of the most intense activities to do during an ISO 9001 implementation is to define the procedures of the business. In this blog, you will learn on how to create the Sales Procedure as per ISO 9001 requirements. Through this blog, we will take the following two examples to explain how the same requirement…
Vision, Mission and KPIs
When thinking of starting any business process re-engineering activities, or if we are considering getting ISO Certified, we need to think about the vision, mission and KPIs for the organization. It is said that “if you don;t have a destination, you can never get lost”, and naturally the inverse also applies. Therefore, before starting any…
The first step enterprises must do for ISO Certification
When thinking about getting ISO certified, business owners ponder about the first step enterprises must do for ISO Certification. Granted, suppliers or customers might be asking you to get certified, and you would want to know more about what it really means to get certified. But the whole process might be dauting, and you might…
How do I prepare for an ISO Audit?
As part of implementing and maintaining an ISO Management System, an Internal Audit and External Audit are required. So, how do I prepare for an ISO Audit? Luke Desira‘s background had led him to have a very different approach to ISO Certification. His first job was at a multi-national corporation employing 45,000 people, and his…
ISO 9001:2015 Management Review Meeting Sample
Having an ISO 9001:2015 Management Review Meeting Sample is a very understandable question for anyone doing a Management Review for the first time. The Management Review Meeting could possibly be the primary source for continual improvement. Given the fact that the Management Review meeting is all about discussing information with the idea or improvement, first…
Risk Management in ISO 9001
Risk Management in ISO 9001 is defined as “the effect of uncertainty” on business objectives. Risk is about dealing with uncertainty. Anything that can have an impact on the strategic direction of a business, can be considered as a risk. If we have no objectives, we are not doing anything. If we have an event without…
ISO 9001 Internal audit for SMEs in Malta
ISO 9001 Internal audit for SMEs in Malta might be a daunting task for some, or an exciting experience through which you actively improve your business. ISO 9001 is a voluntary international quality management standard that forward thinking companies implement within their company to structure their processes. For a company to make a return on…
How long does it take to get ISO Certification?
ISO Certification is increasingly becoming important for forward-looking businesses that are seeking to structure and grow their business. The first consideration that most business owners consider when seeking such a certification is “How much does it cost to get ISO Certified in Malta?”. Like with any other investment that is to be made, the exact…
ISO 15189 – Medical laboratories
Similar to ISO 9001, ISO 15189 Medical laboratories is a Quality Management System. The salient difference is that the latter gives requirements that are specific to medical laboratories. Another standard that is also relevant to medical laboratories is ISO 17025. The main difference between the 2 standards is that: ISO 15189 sets out the guidelines for…
Supplier Management for ISO 9001 Certification
Handling your suppliers within your value chain in a systematic fashion is extremely critical to ensure a high-quality product or service. Supplier Management for ISO 9001 Certification is an easy requirement of the ISO 9001 standard that does not require too much effort from your end – and yet that will leave long-lasting benefits to…
Proper implementation of ISO 9001
As an ISO consultant in Malta, I get the opportunity to work with various types of clients, giving me the opportunity to ‘go under the hood’ of various business. Proper implementation of ISO 9001 depends on the character of the business owner – how will are they to improve their business. Recently I was working…
ISO 9001 Certification Requirements
In this page, you will get a complete overview to learn the ISO 9001 Certification Requirements. Here we will assume that you are very familiar with the benefits of implementing an ISO Certification and that you understand Why ISO Certification is important. Step 1: Get an overview of the Clauses for Certification Step 2: Know…
Building Maintenance Report for ISO 27001 Certification
Recently, I have been asked by one of my clients to produce a Building Maintenance Report for ISO 27001 Certification. Given that apart from being an ISO Consultant, I am a Mechanical Engineer I am competent and authorised to created such reports. Through this blog post, I wanted to share with you the salient elements…
Medical Device Regulations for Distributors & Importers
The Medical Device Regulations for Distributors came into force in mid-May 2021 (after being postponed by 1 year due to Covid-19). Through this regulation, the European Union has streamlined the various fragments of regulations of directives and regulations that previously existing. The idea behind this regulation is to define the level of standard for the…
Corrective actions and non-conformities in ISO 9001
Corrective actions and non-conformities in ISO are the way that we track mistakes that happen within our organisation. In previous blog posts, I have mentioned multiple times that an ISO Certification does not mean that a company has perfect products and service and that no mistakes are done. An ISO 9001 Certification means that a…
Business Process Re-engineering
Business process re-engineering might be a pandora’s box for anyone who has never looked into the subject. But in reality, it is very simple. Basically, it debunks the concept of “never change a winning team”. In business, and in life, we must continually strive to improve our position. Whether going backwards or forwards, in life…
7 Types of Waste in a Business
The 7 Types of Waste in a Business are not an idea that has been around for long. On the contrary, for the past year, lean principles have only been used for manufacturing companies. However now, with the rise of businesses, due attention is being given drive improvement through the management system of companies. Introduction…
Why is ISO Certification important?
There are many reasons why ISO Certification is important, and even though there are many benefits of ISO 9001 certification, it all boils down to one thing, as we will see below. At the outset, I’d like to make it clear that I do not believe that a mere quality certification improves the quality of…
Customer Satisfaction for ISO 9001
Customer satisfaction is a very important aspect of ISO 9001. As we have discussed in earlier posts, having an ISO Certification doesn’t mean that you will have a good quality product. Rather, an ISO Certification, by a reputable certification body, means that you have a strong management system through which you are obtaining real data…
What does it mean to have an ISO certification?
Many people who are looking for an ISO Certification ponder on the idea of “What does it mean to have an ISO certification?” Contrary to popular belief, I will cut to the chase, and say that it does not mean that the company offers a high-quality product or service. Management Systems Before going any further,…
Design & Development procedure as per ISO 9001
Here you will learn more about the Design & Development procedure as per ISO 9001. Design and development could be one of the key processes that need to be defined during an ISO 9001 certification process. If the company does not receive the requirements from the customer or interested parties, and therefore the company designs…
Good Distribution Practise (GDP) Certification in Malta
GDP Certification in Malta refers to the minimum standard that distributors of wholesale products must meet to ensure that good quality medicines are maintained throughout the supply chain. Unlike an ISO certification, GDP is a mandatory requirement for companies involved in the wholesale, or distribution of medicinal products. Even more so, now with the introduction…
What is a management system?
When starting to explain what is a management system one can start off by giving the definition as per ISO, the international standardization organisation “A management system is the way in which an organization manages the interrelated parts of its business in order to achieve its objectives.” ISO.org As can be seen above, a management…
Drive improvement through the management system
The aim of ISO 9001 is to drive improvement through the management system. Going through the process to get ISO Certified without taking any of the benefits of the certification would be a futile exercise. And this is irrespective of the cost to get ISO Certification. ISO 9001 consulting is exciting when companies seek to…
Organizational knowledge in ISO 9001
Organizational knowledge in ISO 9001 is one of the updates of the current version of the standard that aims to focus on a service business. Organisations have a myriad of information coming from different sources that need to be captured. It is said that when making a mistake, the damage caused is partly worthwhile if…
Quality policy for an ISO management system
Creating a Quality policy for an ISO management system might be a daunting task for some. However, from our experience in ISO 9001 consulting, we know that it can be a fun, creative exercise. Strategy first Getting your business ISO Certified, should be a strategic decision for your business. Through the process of getting ISO…
Internal and External Issues
The current version of ISO 9001:2015 has been created in a way that can be used for any type of business. Whether it is a manufacturing company, or a service company seeking ISO Certification, each of the 10 clauses of the standard, are relevant to your business. Through the Internal and External Issues, your company…
Example of Interested Parties for ISO
In this page, you’ll discover some examples of interested parties as required by ISO Certification. The concept of interested parties was not mentioned in the previous version of the ISO 9001 standard. However, in the current version of ISO 9001, it can be considered one of the pillars. for implementing the Quality Management System. Definition…
Which ISO Standard Certification is best?
There are many ISO Certifications available, which might get business managers wondering which ISO certification is best for their business. Management Systems Available ISO, which is the international standardization organization issues standards relating to all the products that we use in our everyday life. As of 2017, there were more than 21,700 ISO standards. That…
What is the new & current ISO 9001 standard?
In this blog post, we will review the current ISO 9001 standard, and all it’s previous versions. ISO stands for International Standardisation Organisation, which is a global network on national standards bodies. This body, issues standards relating to all aspects of the industry. There are several management system standards, including: ISO 9001 – Quality Management…
What is the cost of ISO 9001 Certification?
What is the cost for ISO 9001 Certification? That is the first question any successful business manager would ask before investing in their business. Like for any other investment, many people like to know how much does it cost to get ISO 9001 certification, before deciding to move forward. First of all, it is important…
Service business working from home – Tips for 2020
Most service business have the privilege to keep on working, even with their employees at home. For some other businesses that is impossible (like manufacturing, and retail shops). So, I encourage business owners to make the most of this situation. To look-ahead, because being hopeful, and working towards a better future is the only thing…
Process to get ISO 9001 Certified
Since ISO 9001 is a standard, there should be a process to get ISO 9001 Certified, however most consultants still don’t follow a defined process, with tangible actions and results that will be obtained in each step. At ISO 9001 Malta, we do it different. In this post, we will explain the salient steps to…
Get ISO 9001 Certified Fast
In this post you will find all the information that you need to be able to effectively get ISO 9001 certified Fast. If you know the business that you are running, and if you carefully read everything that’s written in this eBook, you can be ready for the External Audit in 30 days. You should…
Choosing a certification body
The last step towards getting ISO 9001 certification is that of choosing a certification body. The role of consultants is to help you design a quality management system that helps you improve your business, that is compliant with the requirements of ISO 9001 standards. On the other hand, consultants cannot issue ISO 9001 certificates to…
Benefits of ISO 9001 certification
ISO 9001 certification, is a voluntary quality management system certification. The benefits of ISO 9001 certification are dependent on the type of leadership of the organisation. ISO 9001 Certification has been on the increase in Malta for the past years, as it helps businesses structure, and grow their business. If you are only involved in…
ISO 9001 for a Marketing Agency
In this blog post, we will cover the documentation that is needed for ISO 9001:2015 Certification Process by a local service company, specifically for a marketing agency. It is good to note that the content within this blog post can be used by all service companies, for the their fundamental operations are similar. Mandatory Documents…
Does a Quality Certification improve Quality?
ISO 9001 is the most famous quality certification in the World. And that it’s because this certification is accepted and sometimes required by suppliers or customers. Moreover ISO 9001 certification is subsidized by the government through a tax credit scheme offered by Malta Enterprise. Having said that does having an ISO certification in Malta actually…
ISO 9001:2015 Quality Objectives with Examples
Welcome to this blog about iso 9001:2015 quality objectives with examples. In this blog, my main aim is to help you truly understand what the actual requirements of the standard are when it comes to quality objectives. We are also going to go over three case studies of actual companies that have implemented iso 9001….
ISO 9001 Clauses in plain English
On this page, we will explain in detail, the ISO 9001 clauses in plain English. As an introduction, here are the salient elements of these ISO 9001 clauses in plain English. Introduction to ISO 9001 Clauses in plain English Context – What are the internal and external elements affecting the business? Who are the people…
ISO 9001:2015 roles and responsibilities
We all know that human resource is the most important assets that any organization has. Within the current version of ISO 9001:2015 roles and responsibilities are discussed in multiple clauses within the standard, including 5.2 (assigning and communicating roles), 7.1.2 (allocation of staff to meet requirements), and 7.2 (competence and training). The business world, over…
ISO Consultant in Malta
Luke Desira is an ISO Consultant in Malta with over 8 years of experience. Over the years, I have learned, unlearned, and learned again how to implement ISO Certification. Here’s my story. ISO 9001 consultants are outdated ISO 9001 has been around for quite some time. like any other innovation, the standard started off through…